Product Development and Clinical Trials - Azitra, Inc. has developed a proprietary platform with a microbial library of approximately 1,500 unique bacterial strains for precision dermatology[22]. - The company is advancing its lead programs, ATR-12 and ATR-04, into clinical trials, with ATR-12 targeting Netherton syndrome and ATR-04 targeting EGFRi-associated rash[32]. - ATR-12 received Pediatric Rare Disease Designation from the FDA in 2019, and the Phase 1b clinical trial commenced in December 2023, with the first patient dosed in August 2024[23]. - ATR-04 obtained IND clearance from the FDA in August 2024 and Fast Track designation in September 2024, with the first patient dosed in the third quarter of 2025[23]. - The estimated incidence of ichthyosis vulgaris, targeted by ATR-01, is 1 in 250, suggesting a total patient population of approximately 1.3 million in the United States[24]. - ATR-12, a proprietary drug candidate for treating Netherton syndrome, contains a genetically modified strain of S. epidermidis that secretes a fragment of the LEKTI protein, addressing the underlying cause of the disease[45]. - ATR-12 is projected to represent a potential global sales opportunity of $250 million by mid-2030 based on market analysis[46]. - Preclinical studies indicate that SE351, the strain used in ATR-12, can colonize human skin and requires D-alanine for growth, confirming its controlled application[56]. - A single therapeutic dose of ATR-12-351 demonstrated approximately 2-fold higher LEKTI activity after 24 hours compared to 8 hours, indicating sustained production of functional rhLEKTI-D6[60]. - The company filed an IND for a Phase 1b clinical trial of ATR-12 in December 2022, with the first patient dosed in August 2024 and initial safety results expected in the first half of 2025[65]. - The Phase 1/2 clinical trial for ATR-04-484 began in Q3 2025, focusing on safety and quality of life as secondary endpoints[86]. - ATR-01 utilizes a novel engineering segment of human filaggrin to enhance skin delivery, targeting the underlying cause of ichthyosis vulgaris[87]. - ATR-01-616 is a novel topical formulation for treating ichthyosis vulgaris (IV), utilizing a genetically modified S. epidermidis strain to deliver recombinant human filaggrin[92]. - In preclinical studies, ATR-01-616 significantly reduced transepidermal water loss (TEWL) in a damaged pig skin model, achieving p-values <0.001 across all tested doses[94]. - The in vitro model demonstrated that ATR-01-616 restored keratohyalin granules and increased filaggrin levels in reconstructed human epidermis compared to untreated controls[96]. Partnerships and Collaborations - Azitra has established partnerships with Carnegie Mellon University and Fred Hutchinson Cancer Center to enhance its research capabilities and product development[25]. - The company holds an exclusive, worldwide license from Fred Hutch for the use of patented SyMPL technologies in genetic engineering[25]. - The SyMPL technology platform acquired from Fred Hutch allows for the genetic modification of previously intractable bacterial species, expanding the potential for future product candidates[41]. - The exclusive license agreement with Fred Hutchinson Cancer Center allows the company to develop and commercialize products related to SyMPL technologies, with patent rights expiring in 2037 and 2040[121][122]. Financial Performance and Projections - For the fiscal years ended December 31, 2025 and 2024, the company incurred a net loss of $11.0 million and $9.0 million, respectively, with an accumulated deficit of $68.5 million as of December 31, 2025[217]. - The company expects to continue incurring substantial expenses without any meaningful revenues until regulatory approval and successful commercialization of at least one product candidate[218]. - As of December 31, 2025, the company had total assets of $5.0 million and working capital of $2.0 million[220]. - In January 2025, the company completed a public offering of 729,381 shares at an offering price of $2.00 per share, receiving net proceeds of approximately $1.2 million[220]. - In February 2025, the company completed a registered direct offering of 374,696 shares at an offering price of $1.85 per share, receiving net proceeds of approximately $695 thousand[220]. - The company anticipates significant research, regulatory, and development expenses as it advances product candidates towards commercialization[218]. - The report from the independent registered public accounting firm indicates substantial doubt about the company's ability to continue as a going concern due to accumulated deficit and negative cash flow from operations[219]. - The company has a limited operating history and has not commenced revenue-producing operations apart from limited grant and service revenue[215]. Regulatory Environment - The biopharmaceutical industry presents intense competition, with potential competitors having greater financial resources and expertise[102]. - No FDA-approved drug exists for treating EGFRi-associated rash, affecting up to 90% of patients on anti-EGFR therapies[107]. - Pharmaceutical companies face extensive regulations from agencies like the U.S. FDA, impacting research, development, and marketing processes[125]. - The FDA approval process for new biologics includes multiple phases, with significant costs and time requirements, often extending over many years[126][129]. - The company must comply with Good Manufacturing Practices (cGMP) and other regulatory requirements to avoid fines or refusal of marketing applications[125][128]. - The FDA requires compliance with cGMP regulations for the manufacturing of product candidates, which involves significant investment in personnel, facilities, and quality control[138]. - A BLA submission must include comprehensive data from clinical studies, and the FDA aims to complete its initial review within ten months, or six months for serious conditions[141]. - The FDA may approve a BLA with conditions such as post-marketing studies or risk mitigation strategies, which could include REMS plans[142]. - The FDA can designate products for expedited review under Fast Track, Breakthrough Therapy, or Priority Review if they address unmet medical needs[146][149]. - Orphan Drug Designation provides seven years of market exclusivity for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[158]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained, leading to potential fines or product recalls[157]. - Manufacturers must continue to comply with cGMPs post-approval, with periodic inspections by the FDA to ensure ongoing compliance[143]. - The FDA strictly regulates marketing and promotion, allowing products to be promoted only for approved indications[156]. Market and Competitive Landscape - The company aims to build a sustainable pipeline of product candidates while exploring strategic partnerships to accelerate development and expand into new treatment areas[32]. - The company plans to establish a commercial organization in the U.S. to promote live biotherapeutic products and recombinant proteins for skin diseases[100]. - The company expects additional state and federal healthcare reform measures that could limit government payments for healthcare products and services, potentially reducing demand for its product candidates[209]. - Heightened scrutiny over drug pricing practices may lead to increased transparency and potential regulatory changes affecting profitability[203].

Table of Contents Index to Financial Statements UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 1-14569 PLAINS ALL AMERICAN PIPELINE, L.P. (Exact name of registrant as specified in its charter) (State or other jurisdict ...

U.S. Securities and Exchange Commission Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the fiscal year ended November 30, 2025 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number 001-40767 CRYO-CELL INTERNATIONAL, INC. | (Exact Name of registrant as specified in its charter) | | --- | | DELAWARE 22-3023093 | | (State or other jurisdiction of (I.R. ...

Commission file number: 1-10026 ______________________________________________________________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________________________________ FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _ ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________________________________________________________________________ FORM 10-K __________________________________________________________________________________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-K ______________________________________ ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2025 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _____ to _____ Commission file number 001-38600 ______________________________________ TENABLE H ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ COMMISSION FILE NUMBER 001-41550 CROWN HOLDINGS, INC. (Exact name of registrant as specified in its charter) Pennsylvania 75-3099507 (State or other jurisdic ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 1-11442 CHART INDUSTRIES, INC. (Exact name of registrant as specified in its charter) State or other jurisdiction of incorporation or organization 8665 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 0-12508 S&T BANCORP, INC. (Exact name of registrant as specified in its charter) Pennsylvania 25-1434426 (State or other jurisdiction of incorporation ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38593 Establishment Labs Holdings Inc. (Exact name of Registrant as specified in its charter) British Virgin Islands 98 ...